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FDA 510(k) Application Details - K112101
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K112101
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
POLYMED THERAPEUTICS, INC
27001 LA PAZ ROAD,
SUITE 266B
MISSION VIEJO, CA 92691 US
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Contact
TERRI WALLACE
Other 510(k) Applications for this Contact
Regulation Number
862.1155
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Classification Product Code
JHI
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More FDA Info for this Product Code
Date Received
07/22/2011
Decision Date
07/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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